Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock
Authors: Daniel Jost, Sabine Lemoine, Frédéric Lemoine, Clément Derkenne, Sébastien Beaume, Vincent Lanoë, Olga Maurin, Emilie Louis-Delaurière, Maëlle Delacote, Pascal Dang-Minh, Marilyn Franchin-Frattini, René Bihannic, Dominique Savary, Albrice Levrat, Clémence Baudouin, Julie Trichereau, Marina Salomé, Benoit Frattini, Vivien Hong Tuan Ha, Romain Jouffroy, Edouard Seguineau, Rudy Titreville, Florian Roquet, Olivier Stibbe, Benoit Vivien, Catherine Verret, Michel Bignand, Stéphane Travers, Christophe Martinaud, Michel Arock, Mathieu Raux, Bertrand Prunet, Sylvain Ausset, Anne Sailliol, Jean-Pierre Tourtier, Souha Albinni, Arié Attias, Deborah Benchetritt, Laura Benichou, René Bihannic, Stéphane Boizat, Philippe Boutinaud, Alexandra Calinet, Laurence Camoin-Jau, Valérie Cerro, Eric Cesareo, Noureddine Chahir, Carine Chassery, Charlotte Chollet, Anouk Choubard, Gaëlle Clavere, Benoit Clavier, Henri Courtade, Séverine Creppy, Jean-Stéphane David, Emmanuelle de Raucourt, Sophie Debord, Josée Delort, Christine Deruaz-Cunsolo, Isabelle Dettori, Marion Dhers, Patricia Dias, Maxime Diaz, Sophie Dieuset, Pierre-Yves Dubien, François-Xavier Duchateau, Jacques Duranteau, Charlotte Fiot, Bernard Flocard, Vincent Foissaud, Marc Fournier, Anne Francois, Gilles Gaget, Benjamin Garnier, Jean-Louis Gaste, Olivier Grimault, Pierre-Yves Gueugniaud, Zakia Idir, Jerome Burnichon, Didier Journois, Florence Blanc-Jouvan, Francois Kerbaul, Isabelle Klein, Blandine Lafitte, Olivier Langeron, Bernard Lassale, Marie Lebouc, Eric Lecarpentier, Stephanie Lejeune, Mickaël Lemaire, Catherine Leniger, Marc Leone, Claudie Leostic, Chantal Lutomski, Marianne Sailliol, Claude-Denis Martin, Catherine Matheron, Jacques Mathieu, Anne-Christine Mendes, Romain Mermillod-Blondin, Arthur Neuschwander, Nathalie Oueidat, Mehdi Ould-Ahmed, Yves Ozier, Catherine Paugam, Franck Peduzzi, Alexandre Petermann, Eric Peytel, Muriel Picou-Leblanc, David Pinero, Patrick Plaisance, Michel Raba, Damien Ricard, Isabelle Romanacce, Thomas Rossignol, Christine Rougelin-Clapasson, Amelie Saint-Paul, Salim Idri, Christine Scotto, Laurence Senent, David Smadja, Karim Tazarourte, Francois Topin, Catherine Trichet, Alexia Vocel
Journal: JAMA Network Open (2022)

<h3>Importance</h3> Blood transfusion is a mainstay of therapy for trauma-induced coagulopathy, but the optimal modalities for plasma transfusion in the prehospital setting remain to be defined. <h3>Objective</h3> To determine whether lyophilized plasma transfusion can reduce the incidence of trauma-induced coagulopathy compared with standard care consisting of normal saline infusion. <h3>Design, Setting, and Participants</h3> This randomized clinical trial was performed at multiple centers in France involving prehospital medical teams. Participants included 150 adults with trauma who were at risk for hemorrhagic shock and associated coagulopathy between April 1, 2016, and September 30, 2019, with a 28-day follow-up. Data were analyzed from November 1, 2019, to July 1, 2020. <h3>Intervention</h3> Patients were randomized in a 1:1 ratio to receive either plasma or standard care with normal saline infusion (control). <h3>Main Outcomes and Measures</h3> The primary outcome was the international normalized ratio (INR) on arrival at the hospital. Secondary outcomes included the need for massive transfusion and 30-day survival. As a safety outcome, prespecified adverse events included thrombosis, transfusion-related acute lung injury, and transfusion-associated circulatory overload. <h3>Results</h3> Among 150 randomized patients, 134 were included in the analysis (median age, 34 [IQR, 26-49] years; 110 men [82.1%]), with 68 in the plasma group and 66 in the control group. Median INR values were 1.21 (IQR, 1.12-1.49) in the plasma group and 1.20 (IQR, 1.10-1.39) in the control group (median difference, −0.01 [IQR, −0.09 to 0.08];<i>P</i> = .88). The groups did not differ significantly in the need for massive transfusion (7 [10.3%] vs 4 [6.1%]; relative risk, 1.78 [95% CI, 0.42-8.68];<i>P</i> = .37) or 30-day survival (hazard ratio for death, 1.07 [95% CI, 0.44-2.61];<i>P</i> = .89). In the full intention-to-treat population (n = 150), the groups did not differ in the rates of any of the prespecified adverse events. <h3>Conclusions and Relevance</h3> In this randomized clinical trial including severely injured patients at risk for hemorrhagic shock and associated coagulopathy, prehospital transfusion of lyophilized plasma was not associated with significant differences in INR values vs standard care with normal saline infusion. Nevertheless, these findings show that lyophilized plasma transfusion is a feasible and safe procedure for this patient population. <h3>Trial Registration</h3> ClinicalTrials.gov Identifier:NCT02736812